Low Dose Radiotherapy in COVID-19 Pneumonia

COVID Clinical Trial

Official title:

Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04390412
• Other study ID #: 23568
• Secondary ID: IRCT202005090473
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 4, 2020
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.

Description:

SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.

Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.

In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.

A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)

• Presence of pulmonary involvement ( defined by P/F ratio or NIV need)

• Less than 3 days since the onset of ARDS

• Age > 60 years

• ? IL-6 ( if available)

• ? CRP

Exclusion Criteria:

• Lack of informed consent

• Inability to transfer to the radiation unit

• Hemodynamic instability

• Septic shock and organ dysfunction

• Severe ARDS P/F ratio = 100 mmHg

• History of cardiac failure

• Contraindications to radiation

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome

Intervention

Radiation:
• Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Hossein Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70. — View Citation

Clayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020

Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. — View Citation

Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. — View Citation

Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rödel C, Weiss C, Rödel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8. — View Citation

Stefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline blood oxygenation	O2 saturation	28 days
Primary	Number of Hospital stay days	Total days the patient is admitted to hospital	28 days
Primary	Number of ICU stay days	Total days the patient is admitted to ICU	28 days
Primary	Number of intubation events	Total number of intubations performed after the treatment	28 days
Secondary	WBC	Changes in WBC count if base-line is abnormal	28 days
Secondary	Platelets	Changes in Platelets count if base-line is abnormal	28 days
Secondary	CRP	Changes in CRP serum level	Day 1
Secondary	CRP	Changes in CRP serum level	Day 2
Secondary	CRP	Changes in CRP serum level	Day 3
Secondary	CRP	Changes in CRP serum level	Day 4
Secondary	CRP	Changes in CRP serum level	Day 5
Secondary	IL-6	Changes in IL-6 serum level	Day 1
Secondary	IL-6	Changes in IL-6 serum level	Day 2
Secondary	IL-6	Changes in IL-6 serum level	Day 3
Secondary	IL-6	Changes in IL-6 serum level	Day 4
Secondary	IL-6	Changes in IL-6 serum level	Day 5